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Team Leader USP Development
Global Biologics Company
The Upstream Process Development team are responsible for the end-to-end development of processes from the early use process development right through to technical transfers to manufacturing. This department works in teams of scientists and develop from 2L scale up to 10L scale carrying out screening experiments to characterize the process from shake flask to production bioreactor and then to harvest.
As a team leader in upstream process development, you will be supervising a team of Scientists and you are responsible for providing technical and scientific leadership and guidance to the USP development team to ensure efficient development and characterization of an upstream process.
- Write/review/approve appropriate written procedures, technical documents, reports and other cGMP documentations.
- Support technology transfer with manufacturing (internal and external), scale up/down, troubleshooting and regulatory submissions.
- Contribute to successful commercial Pre-Approval Inspections, regular Audits and any other interactions with regulatory agencies as required.
- Maintaining leading-edge knowledge and understanding of new technologies in the field of USP process development and proactively share knowledge with the team.
- Responsible for leading and coordinating the development team activities in a safe and EHS/regulatory compliant manner.
- Responsible for keeping the USP team engaged, motivated and enabled to achieve the upstream development planning.
- Ensure USP development labs and equipment are maintained in orderly fashion.
Competencies required to fulfil the employee responsibilities and work assignments:
- An employee shall follow the job description that pertains to his/her position. In addition, an employee shall follow the SOPs that pertains to his/her position.
- An employee shall adhere to the company etiquette in all matters of behaviour and manners. The employee shall take the initiative when solving a task assigned to him/her and do whatever is necessary to solve it.
- It is important that an employee has the company values at heart in his/her work.
- An employee shall be actively involved in tasks that involve other departments in the company, in addition to other tasks assigned to him/her
EDUCATION AND EXPERIENCE
- Life Sciences Degree
- Minimum of 5 years’ experience in biopharmaceuticals or technical field desired.
- Knowledge of upstream development activities (lab scale (=must) and production scale) including hands-on expertise operating upstream equipment.
- Demonstrated ability to lead, manage and motivate people and their activities
- Experience with fed-batch and perfusion mode
- Experience with screening experiments (Ambr or comparable)
- Experience applying QbD (quality by design) and DoE approach to develop and trouble shoot development activities.
- Experience in harvesting techniques
- Experience in process characterization, process validation
- Understanding of scale up / scale down
- Understanding of statistical methods and implementation
Personal and Leadership Qualities:
- Strong verbal and written communication skills to communicate effectively within the department and to other departments.
- Displays strong problem-solving, pro-active attitude.
- Must be strong in time management, planning and organizational skills
- Works in a collaborative, constructive and respectfully manner with all colleagues within and across departments.
- Demonstrated ability to work with flexibility in a changing and demanding environment
Ability to delegate tasks and support growth of others